Sr Mgr Qa Operations

J&J FAMILY OF COMPANIES

Sassenheim, Netherlands
Base: 80,800 euro to 140,530 euro annually; bonus/...
Not specified (assumed onsite due to role requirements).
Gmp standards compliance
Aseptic manufacturing oversight
Batch record review and release
Johnson & Johnson is seeking a Senior Manager of Quality Assurance Operations for its Sassenheim facility, focusing on ensuring compliance with GMP standards in the manufacturing of Lentiviral vector products. The ideal candidate will have extensive leadership experience in quality management systems, particularly in aseptic manufacturing, and a commitment to upholding high-quality standards in healthcare innovation

Job Summary

  • The Senior Manager leads the QA Operations team to ensure JBV quality systems are applied according to GMP standards for Lentiviral vector products.
  • This role involves managing batch releases, QP dispositions, and resolving complex quality issues while collaborating closely with production and QC laboratories.
  • The position requires a leader with deep regulatory knowledge who can influence corporate expectations and maintain site compliance during inspections.

Matching Summary

Match Score: 85

Johnson & Johnson is seeking a Senior Manager of Quality Assurance Operations for its Sassenheim facility, focusing on ensuring compliance with GMP standards in the manufacturing of Lentiviral vector products. The ideal candidate will have extensive leadership experience in quality management systems, particularly in aseptic manufacturing, and a commitment to upholding high-quality standards in healthcare innovation.

Salary

Base: 80,800 Euro to 140,530 Euro annually; Bonus/Equity: Not specified; Benefits: 8% holiday allowance included

Skills & Requirements

Must-have

  • GMP standards compliance
  • Aseptic manufacturing oversight
  • Batch record review and release
  • CAPA and non-conformance management
  • Team leadership in QA operations
  • Regulatory inspection readiness

Nice-to-have

  • Inclusive leadership style
  • Cross-functional collaboration skills
  • Strategic decision-making ability
  • Experience with viral vector products
  • Strong ethical commitment

Key Requirements

  • Master's degree in biosciences or engineering
  • Minimum 10 years of Quality experience
  • 5-7 years in managerial people-leading roles
  • Deep understanding of cGMP/ICH/FDA/EMA guidelines
  • Fluency in Dutch and English required

Work Rights

Not specified

Tailored Resume

Cover Letter